IMS Health and Quintiles have come together to be IQVIA. We have created a new way to harness advances in technology, analytics and human ingenuity called Human Data Science, to deliver solutions that help our customers drive healthcare forward and help patients around the globe. Inspired by the industry we help, our employees are committed to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
Perform a variety of clinical procedures to collect, record, report and interpret data on volunteers enrolled and/or seeking enrollment in clinical studies according to standard operating procedures (SOPs). Monitor volunteer response to evaluate effect of investigational drug. Assist with daily workload planning.
• Incumbents in this job classification may work in the clinic, screening, recruitment, laboratories or any other department into which they have cross trained, and may be expected to perform duties not specified below. They may also specialize in particular aspects of this job such as training, staffing or study coordination, and may not be required to carry out all responsibilities indicated below.
• Collaborate with the Study Director/Coordinator to prepare for and execute assigned studies. Assist in ensuring that study objectives are met on time, within budget and according to applicable regulations and quality standards.
• Captain/lead studies, including:
• Review of study protocols, case report forms (CRF), other study documents, and electronic data capture systems;
• Feedback on clinical strategy and concerns;
• Clinical set-up and preparation of the study including labeling specimen collection tubes and containers, setting up
equipment and documents;
• Plani logistical activity for procedures as per protocol;
• Generate materials, documents, and records;
• Attend or delegating all relevant study meetings including those with clients;
• Troubleshoot issues on study;
• Participate in huddles to ensure daily tasks are assigned to team members and are executed to the expected
• Assist with data quality checking and query resolution.
• Orient volunteers to the study and the unit including the purpose of the study, procedures, and protocol issues such as timelines for visits and restrictions on food and drink
• Collect, record and maintain volunteer study data according to study-specific protocol and SOPs ensuring quality control for content, accuracy and completeness.
• Perform a variety of complex clinical procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring. Record, report and interpret findings appropriately to develop study-specific database.
• Centrifuge, aliquot, store and log samples appropriately.
• Perform routine analysis of volunteer specimens according to SOPs. Evaluate specimen acceptability upon receipt and during the review of analysis results. Perform secondary review of volunteers' results when required to ensure accuracy of primary result entry.
• Monitor volunteer safety and report adverse reactions to appropriate medical personnel. Attend to volunteer needs and requirements
• Maintain and restock medical supplies as needed. Maintain cleanliness and sanitation of the unit.
• Provide training to new staff members on study-specific topics and new clinical skills Assist in ensuring compliance with staff training requirements by auditing and maintaining training records. Contribute to development of employees' training plans by advising Team Leads of continuing education requirements and opportunities.
• Recruit and screen volunteers for trials and maintain volunteer database.
• Participate in quality and process improvement efforts to support the culture towards a high-performing and efficient team.
• Assist with planning related to staffing and scheduling. Assist in ensuring that work shifts are staffed as required by sourcing internal staff, booking bank or PRN staff, updating the scheduling system, and notifying staff of assignments.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• Working knowledge of Phase I clinical trials
• Working knowledge of the principles of Good Clinical Practices (GCP)
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry testing
• Good skill in using MS Windows and Office applications such as Access, Outlook and Word
• Excellent interpersonal skills
• Ability to pay close attention to detail
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
• Bachelor's degree or educational equivalent; or High school diploma and 3 years' relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience
• Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
• Use of telephone and face-to-face communication requiring accurate perception of speech
• Use of keyboard requiring repetitive motion of fingers
• Frequent mobilization around the facility
• Occasional lifting and moving objects weighing up to 10 lbs/4.5 kg
Meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimage healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and help patients around the globe. Whatever your career goals, we're here to confidently get you there!
A little about us:
IQVIA™ has approximately 55,000 employees in more than 100 countries, all committed to making the potential of Human Data Science a reality, and we are actively hiring.